Julia Vitarello with her daughter Mila (8) who has a rare neurological disorder, at their home in Colorado. Photograph: Nick Cote/The New York Times

A new drug, created to treat just one patient, has pushed the bounds of personalised medicine and has raised unexplored regulatory and ethical questio(...)

Janet Woodcock, FDA director of the agency’s Center for Drug Evaluation and Research: Amarin has taken a pre-emptive First Amendment case, accusing the FDA of restricting its right to free speech

The US Food and Drug Administration seems mildly discomfited. It’s not a state that one usually associates with the most powerful regulator of the pha(...)